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Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.

Primary Purpose

Hypoxemic Respiratory Failure, Hypercapnic Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
BIPAP, Intelligent automatic mode defined by assured volume with pressure support
BIPAP, manual tritration.
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxemic Respiratory Failure focused on measuring NIV, hypoxemia, hypercapnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: chronic respiratory failure

  • Diurnal hipercapnia and/or nocturnal hypoventilation (CT90% >10%)

Exclusion Criteria:

  • Under 18 years old.
  • Presence of severe uncontrolled cardiac comorbidity.
  • Impossibility to achieve adaptation to therapy in the training session.

Sites / Locations

  • Hospital Clinic Barcelona.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MANUAL

AUTOMATIC

Arm Description

Manual titration of non-invasive mechanical ventilation using polysomnography and randomized

Automatic titration of the non-invasive mechanical ventilation using the same device in an automatic mode with assured volume and pressure support.

Outcomes

Primary Outcome Measures

Partial pressure of carbon dioxide (PaCO2)
Measure levels after each polysomnography using arterial blood gases
Partial pressure of oxygen (PaO2)
Measure levels after each polysomnography using arterial blood gases

Secondary Outcome Measures

Oxygen saving time below 90% (CT90%)
Assess the polysomnography reduction in CT90% through the night study.

Full Information

First Posted
March 7, 2019
Last Updated
March 18, 2019
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT03872167
Brief Title
Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.
Official Title
Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode in Patients With NIV Criteria.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
May 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the polysomnographic performance of an automatic ventilatory mode compared with the gold standard (manual polysomnographic titration) to adjust chronic non-invasive ventilation by means of a randomized cross-over study.
Detailed Description
Prospective randomized crossover study in 26 patients with chronic non-invasive ventilation (NIV) criteria, comparing the NIV titration with polysomnography vs an automatic mode of ventilation. It will be compared with clinical parameters of ventilation, blood analysis and inflammation reactants as well as evaluating the patient's comfort after each mode.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemic Respiratory Failure, Hypercapnic Respiratory Failure
Keywords
NIV, hypoxemia, hypercapnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MANUAL
Arm Type
Active Comparator
Arm Description
Manual titration of non-invasive mechanical ventilation using polysomnography and randomized
Arm Title
AUTOMATIC
Arm Type
Active Comparator
Arm Description
Automatic titration of the non-invasive mechanical ventilation using the same device in an automatic mode with assured volume and pressure support.
Intervention Type
Device
Intervention Name(s)
BIPAP, Intelligent automatic mode defined by assured volume with pressure support
Intervention Description
Correction of night ventilation through an automatic mode of ventilation with assured volume with pressure support
Intervention Type
Device
Intervention Name(s)
BIPAP, manual tritration.
Intervention Description
Correction of night ventilation through a manual titration of non-invasive mechanical ventilation using polysomnography.
Primary Outcome Measure Information:
Title
Partial pressure of carbon dioxide (PaCO2)
Description
Measure levels after each polysomnography using arterial blood gases
Time Frame
two weeks
Title
Partial pressure of oxygen (PaO2)
Description
Measure levels after each polysomnography using arterial blood gases
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Oxygen saving time below 90% (CT90%)
Description
Assess the polysomnography reduction in CT90% through the night study.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic respiratory failure Diurnal hipercapnia and/or nocturnal hypoventilation (CT90% >10%) Exclusion Criteria: Under 18 years old. Presence of severe uncontrolled cardiac comorbidity. Impossibility to achieve adaptation to therapy in the training session.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MONICA C MATUTE VILLACIS, MD
Phone
932275746
Email
matute@clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CRISTINA EMBID LOPEZ, PHD
Organizational Affiliation
Hospital Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic Barcelona.
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hospital Clinic
Email
matute@clinic.cat
First Name & Middle Initial & Last Name & Degree
Monica C Matute Villacís, Pneumology
First Name & Middle Initial & Last Name & Degree
Cristina Embid Lopez, Pneumology

12. IPD Sharing Statement

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Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.

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